Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
NCT07175025

The New Empowerment After eXposure to Trauma (NEXT) Study

Led by Indiana University · Updated on 2025-11-19

106

Participants Needed

1

Research Sites

150 weeks

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The NEXT Study is a randomized controlled pilot examining the feasibility and acceptability of a revised perinatal PTSD protocol. This study will randomize perinatal participants with PTSD to receive NET (n=45); treatment group) and will be compared to perinatal women randomized to usual care (n=45; comparator group). The overall objective of this project is to determine the most feasible and acceptable protocol for a brief virtual perinatal PTSD intervention.

CONDITIONS

Official Title

The New Empowerment After eXposure to Trauma (NEXT) Study

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Able to read and speak English
  • Diagnosis of probable PTSD as determined by the PTSD Checklist for DSM-5 (PCL-5)
  • Pregnant or postpartum (delivered within 16 weeks) at the time of the eligibility screen
Not Eligible

You will not qualify if you...

  • Current severe suicide risk
  • Current psychotic or manic symptoms
  • Cognitive impairment
  • Concurrent trauma-focused psychotherapy
  • Medical advice limiting participation in exposure therapy
  • Current legal actions related to trauma
  • Does not meet criteria for PTSD
  • Not pregnant or delivered more than 12 weeks after timing of eligibility screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

M

Michelle L. Miller, PhD

CONTACT

N

Neva Brown, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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